Medication adherence program: adherence challenges and interventions in type 2 diabetes.

OBJECTIVES: To describe medication adherence problems for adults with type 2 diabetes and to assess the nature and frequency of pharmacist activities in addressing them and proximate outcomes. DESIGN: Pre-post analysis. SETTING: Four community chain pharmacies located in Seattle, WA, from April 2008 to October 2009. PATIENTS: 120 patients (mean age >60 years) with type 2 diabetes taking oral diabetes medications and who were 6 or more days late for refills. INTERVENTION: Pharmacist telephone-initiated adherence support. MAIN OUTCOMES MEASURES: Nature and frequency of adherence-related problems and intervention activities and impact on reduction in refill gaps. RESULTS: The primary adherence challenge was difficulty taking medications (27.1%). Failure to remember doses and forgetting refills were reported by 24.6% and 26.3% of patients at baseline, respectively. Pharmacists provided support through some form of patient education (35.6% of encounters) or other adherence support (40.7%). Pharmacist time averaged slightly greater than 5 minutes per intervention and 12.6 ± 10.7 minutes (mean ± SD) over 12 months, with 3.4 ± 2.4 interventions per patient. Patient-specific education and adherence support by pharmacists and total intervention time were positively correlated, with a modest but significant reduction in refill gaps during 12 months of follow-up. CONCLUSION: Not remembering to refill medications was the most commonly reported problem. Patient encounters averaged 4 to 6 minutes for the first visit and 12 to 13 minutes over 12 months. Phone calls by pharmacists to adults who were late for oral diabetes medication refills were effective in identifying adherence-related problems and developing support strategies to promote medication self-management in busy urban community chain pharmacy settings.

MAP study: RCT of a medication adherence program for patients with type 2 diabetes.

OBJECTIVE: To evaluate the impact of a community pharmacy-based medication adherence detection and intervention protocol on medication adherence for patients with diabetes. DESIGN: Randomized controlled trial. SETTING: Four community chain pharmacies in the Seattle, WA, area from April 2008 to October 2009. PATIENTS: Patients with diabetes (n = 265) who were taking oral diabetes medications and late for refills by 6 days or more. INTERVENTION: Telephone-initiated adherence support by pharmacists following computer-generated missed refill alerts. Patients were randomized at the pharmacy level with pharmacists blinded to randomization. MAIN OUTCOMES MEASURES: Changes in medication adherence (i.e., days late at first refill, percent with a refill gap of 6 days or more at first refill, medication possession ratio [MPR] at 6 and 12 months) measured during three time periods. RESULTS: Baseline MPR (previous 12 months) of oral diabetes medications for study versus control participants was relatively high and similar (0.86 and 0.84, respectively). At 12 months, MPR was significantly improved for the study group ( P = 0.004) compared with the control group (difference between groups, P = 0.01). The intervention showed greater effect for patients with baseline MPR less than 80% (difference between groups, P = 0.02). The likelihood of MPR above 80% at the 12-month follow-up for any patient significantly favored the intervention group (odds ratio 4.77 [95% CI 2.00-11.40]). CONCLUSION: A brief missed refill intervention program involving urban community chain pharmacies was effective in achieving improved diabetes medication adherence, particularly among individuals with baseline MPR of 0.80 or less.

Healthcare costs of atypical antipsychotic use for patients with bipolar disorder in a Medicaid programme.

BACKGROUND: A large body of clinical studies have demonstrated the efficacy of atypical antipsychotic use in the treatment of bipolar disorder. Facing increasing budget pressure, third-party payers, such as state Medicaid programmes in the US, are demanding better understanding of the medical costs beyond atypical antipsychotic drug costs alone in treating bipolar disorder. OBJECTIVE: To examine healthcare costs associated with the atypical antipsychotic treatments for bipolar disorder from a US third-party payer perspective. METHODS: This was a retrospective cohort study using an intent-to-treat approach. Using the North Carolina Medicaid claims database (August 2000 to January 2005), 3328 patients with bipolar disorder were identified who were continuously eligible for 3 months pre-initiation and 12 months post-initiation of treatment with an atypical antipsychotic (AP2) or mood stabilizer (MS). Patients were classified into three groups based on the treatment types during the first 30 days after treatment initiation: AP2 monotherapy, AP2 + MS combination therapy, and MS monotherapy. Bipolar-related and total health-related costs were examined for the 12-month period. Propensity score matching was employed to balance baseline characteristics among the three comparison groups. Generalized linear models were further employed to estimate the average treatment effect on the cost outcomes. RESULTS: Compared with MS monotherapy, AP2 monotherapy and AP2 + MS combination therapy incurred higher medication costs during the 12-month treatment period. Patients receiving AP2 monotherapy had significantly lower bipolar-related medical costs (-$US698; p = 0.002) [year 2004 values] than patients receiving MS monotherapy. However, the inclusion of the medication cost produced no statistically significant difference in bipolar-related total cost (p = 0.14). Similar results were observed for all health-related costs. Patients receiving AP2 + MS therapy incurred significantly higher bipolar-related total costs (+$US1659; p < 0.0001) and all health-related total costs (+$US2115; p < 0.0001) than patients receiving MS monotherapy, which was attributable largely to the higher medication cost. CONCLUSIONS: From a third-party payer perspective, atypical antipsychotic monotherapy generated higher drug costs but lower medical care costs, resulting in equivalent total healthcare costs over a 1-year period.

Analysis of the North Carolina long-term care polypharmacy initiative: a multiple-cohort approach using propensity-score matching for both evaluation and targeting.

BACKGROUND: The high cost and undesirable consequences of polypharmacy are well-recognized problems among elderly long-term care (LTC) residents. Despite the implementation of the 1987 Omnibus Budget Reconciliation Act, which requires pharmacist review of drug regimens in this setting, medical and drug costs for LTC residents have continued to increase. OBJECTIVE: This study evaluates the North Carolina Long-Term Care Polypharmacy Initiative, a large-scale medication therapy management program (MTMP) that combined drug utilization review activities with drug regimen review techniques. METHODS: This was a prospective records-based study that used a difference-in-difference model with both historical and nonintervention group controls. To ensure equivalence among subjects, propensity scoring was used to match study subjects from participating LTC facilities with comparison subjects from nonparticipating facilities. Residents with interventions were grouped for analysis by intervention type-retrospective only, prospective only, or dual type (residents with both prospective and retrospective interventions)-and by intervention stage-review, recommendation, and drug change-plus an all-inclusive "all types" grouping that aggregated groups by intervention type, for a total of 10 total cohorts. RESULTS: In the overall population of 5255 study subjects identified, a US $21.63 per member per month drug-cost savings was observed. Although only 1 of 10 cohorts had a change in the number of drug fills, substantial reductions in 2 of 5 types of drug alerts were observed in all 10 cohorts. A reduction in the relative risk for hospitalization (0.84 [95% CI, 0.71-1.00]) was observed in the cohort of residents receiving a retrospective review. CONCLUSIONS: This Initiative suggests that an MTMP can be quickly launched in a large number of LTC facility residents to produce monetary drug-cost savings and improved health outcomes. Additionally, the evaluation of this program illustrates the utility of using propensity scoring techniques to target future intervention groups in a cost-effective manner.

Cost analysis in a Medicaid program for patients with bipolar disorder who initiated atypical antipsychotic monotherapy.

BACKGROUND: Use of atypical antipsychotics in treatment of patients with bipolar disorder is increasingly common, yet few studies have systematically investigated or compared medical costs associated with use of specific atypical antipsychotics. OBJECTIVE: To evaluate the direct healthcare costs associated with olanzapine, risperidone, or quetiapine monotherapy among Medicaid patients diagnosed with bipolar disorder (ICD-9: 296.4x-296.8x). METHODS: North Carolina Medicaid patients with bipolar disorder were followed for 12 months after initiation of atypical antipsychotic monotherapy (index date). They had no bipolar-related medical visit, hospitalization, or use of atypical antipsychotics 90-days prior to the treatment initiation. Costs of index drug, all bipolar-related medical care, and all health-related costs were examined. A two-stage sample selection model was employed to account for potential confounders and sample selection bias. Medication adherence measures using cumulative medication acquisition and cumulative medication gap were calculated as separate outcomes. RESULTS: Inclusion criteria were met by 838 continuously eligible patients (393 olanzapine, 262 risperidone, 183 quetiapine). Drug-taking adherence was similar across the drug cohorts. After adjusting for potential confounders, patients taking olanzapine incurred $863 (p < 0.001) and $449 higher (p < 0.01) index drug costs than patients taking risperidone and quetiapine, respectively. Bipolar-related medical costs for patients taking olanzapine were higher ($616; p = 0.06) than for patients taking risperidone at 10% significance level, while such costs for patients taking olanzapine and quetiapine were similar. Total health-related costs did not differ across patient cohorts, including or excluding the index drug costs. LIMITATIONS: The final study sample is a highly selected one based on the study design. This sample may not represent the entire bipolar population. The criteria used to guard against omitting bipolar disorder patients misdiagnosed with major depression need further validation. CONCLUSIONS: No evidence was identified that there is any difference for total health-related costs in using olanzapine, risperidone, or quetiapine monotherapy to treat bipolar disorder, from a Medicaid payer's perspective. The clinical difference between these atypical antipsychotic drugs for the treatment of bipolar disorder could be of more interest than the economic difference.

Review and analysis of hospitalization costs associated with antipsychotic nonadherence in the treatment of schizophrenia in the United States.

OBJECTIVE: To review the literature addressing the economic outcomes of nonadherence in the treatment of schizophrenia, and to utilize the review results to provide an update on the economic impact of hospitalizations among schizophrenia patients related to antipsychotic nonadherence. METHODS: A structured search of EMBASE, Ovid MEDLINE, PubMed and PsycINFO for years 1995-2007 was conducted to identify published English-language articles addressing the economic impact of antipsychotic nonadherence in schizophrenia. The following key words were used in the search: compliance, noncompliance, adherence, nonadherence, relapse, economic, cost, and schizophrenia. A bibliographic search of retrieved articles was performed to identify additional studies. For a study to be included, the date of publication had to be from 1/1/1995 to 6/1/2007, and the impact of nonadherence had to be measured in terms of direct healthcare costs or inpatient days. Subsequently, an estimate of incremental hospitalization costs related to antipsychotic non adherence was extrapolated at the US national level based on the reviewed studies (nonadherence rate and hospitalization rate) and the National Inpatient Sample of Healthcare Cost and Utilization Project (average daily hospitalization costs). RESULTS: Seven studies were identified and reviewed based on the study design, measurement of medication nonadherence, study setting, and cost outcome results. Despite the varied adherence measures across studies, all articles reviewed showed that antipsychotic nonadherence was related to an increase in hospitalization rate, hospital days or hospital costs. We also estimated that the national rehospitalization costs related to antipsychotic nonadherence was $1479 million, ranging from $1392 million to $1826 million in the US in 2005. LIMITATIONS: The estimate of rehospitalization costs was restricted to schizophrenia patients from the Medicaid program. Additionally, the studies we reviewed did not capture the newer antipsychotic drugs (ziprasidone, aripiprazole and paliperidone). Thus, the nonadherence rates or rehospitalization rates might have changed after these new drugs came to the market, which could limit our cost estimation. CONCLUSIONS: Poor adherence to antipsychotic medications was consistently associated with higher risk of relapse and rehospitalization and higher hospitalization costs. To reduce the cost of hospitalizations among schizophrenia patients, it seems clear that efforts to increase medication adherence should be undertaken.

Evaluation of a pilot medication therapy management project within the North Carolina State Health Plan.

OBJECTIVE: To assess the feasibility of a pharmacist-based medication therapy management (MTM) service for North Carolina State Health Plan enrollees. DESIGN: Before/after design with two control groups. SETTING: Community pharmacies and an ambulatory care clinic in North Carolina serving patients from October 2004 to March 2005. PARTICIPANTS: 67 patients who used a large number of prescription drugs, 10 community/ambulatory care pharmacists, and more than 600 participants from two control groups. INTERVENTIONS: Pharmacist-conducted MTM reviews for volunteering patients. MAIN OUTCOME MEASURES: Process measures (type and frequency of drug therapy problems detected and services performed), economic measures (number and cost of medications dispensed), and humanistic measures (patient satisfaction with services). RESULTS: Pharmacists identified an average of 3.6 potential drug therapy problems (PDTPs) per patient at the first visit. The most common PDTP categories were "potential underuse" and "more cost-effective drug available." Pharmacist actions were divided nearly equally between activities that would result in increased and decreased drug use. Pharmacists recommended a drug therapy change in about 50% of patients and contacted the prescriber more than 85% of the time. About 50% of patients with PDTPs had a change in drug therapy. Prescription use during the postintervention period decreased in both the study and control groups but was statistically significant only among the control groups. No significant differences were observed in patient co-payment or insurer prescription costs. Pharmacists provided the following educational services: medication use (90%), disease management (88%), adherence, and self-care (60%). Survey results indicated that patients highly valued the service. CONCLUSION: A voluntary MTM program targeted at ambulatory patients using a large number of medications reduced the number of PDTPs but did not necessarily result in reductions in prescription drug use or cost. Nearly all patients received some form of medication adherence or disease education associated with problem detection and resolution. Patient satisfaction levels with the service were very high.

Effect of second-generation antidepressants on mania- and depression-related visits in adults with bipolar disorder: a retrospective study.

OBJECTIVE: To assess the effect of second-generation antidepressants on mania-related and depression-related office visits for adults with bipolar disorder. METHODS: Using a national managed-care claims database, we retrospectively identified continuously enrolled patients with bipolar disorder who had a new antidepressive prescription treatment between January 1998 and December 2002. Patients were followed for at least 12 months after the date of initial use of antidepressant monotherapy, mood stabilizer monotherapy, or antidepressant-mood stabilizer combination therapy. Logit models with propensity score matching were used to identify the relationship between treatment types and the likelihood of having mania-related visits within 12 months. Negative binomial models and Cox proportional hazard models were used to predict the number of depression-related visits and time to first mania- or depression-related visit. RESULTS: Patients on antidepressant monotherapy and combination therapy did not have different likelihoods of mania-related visits compared with those on mood stabilizer monotherapy (with odds ratios (ORs) 0.67 (95% confidence interval (CI) 0.42-1.04) and 0.99 (95% CI 0.69-1.43), respectively). The numbers of depression-related visits for the same comparisons were significantly lower, with incidence rate ratios of 0.68 (95% CI 0.56-0.82) and 0.65 (95% CI 0.52-0.81), respectively. The results of time to first mania- or depression-related visit provided similar indications. CONCLUSIONS: Second-generation antidepressant was associated with a decreased number of depression-related visits but was not associated with an increased risk of mania-related visits within a 1-year period. Although more work is needed to establish the safety and efficacy of second-generation antidepressants in treating bipolar depression, the evidence from this study supports a favorable risk-benefit profile.

Medication therapy management services in North Carolina community pharmacies: current practice patterns and projected demand.

OBJECTIVE: To evaluate the types of cognitive services offered and the number of patients being served in community pharmacies, determine the number of pharmacies that plan to offer medication therapy management (MTM) services under the Medicare Part D prescription drug benefit, and assess whether current and expected practices will meet the potential needs of enrollees. DESIGN: Cross-sectional study. SETTING: North Carolina in January 2005. PARTICIPANTS: 1,593 community pharmacy managers. INTERVENTIONS: Survey using a Web-based tool. MAIN OUTCOME MEASURES: Provision of cognitive services and number of patients for whom services are provided. RESULTS: A total of 262 (16%) pharmacy managers provided usable responses. Approximately 42% of respondents (n = 110) indicated that they provide some type of cognitive service. Comprehensive MTM services, or services consistent with the professionwide consensus definition, were provided by 31% of respondents (n = 81). Independent pharmacies were more likely to offer some type of service compared with chain pharmacies (58% versus 31%, respectively; P < .001). Pharmacy managers with a doctor of pharmacy degree were less likely than pharmacy managers with a bachelor's degree to offer services in their pharmacies (P = .02), and pharmacies with pharmacists on staff who had received certificate training were more likely to offer cognitive services (P = .03). Of all respondents, 28% (n = 73) indicated that they planned to offer MTM services under the Medicare Part D prescription drug benefit. CONCLUSION: Comparing these results with those of a 1999 survey of North Carolina pharmacists that used some of the same items, the percentage of community pharmacies that provide cognitive services has increased in the intervening years but remains low. Among the services being offered in 2005, most were focused on patient education and training, coordinating and integrating care, and medication regimen reviews. Implementation of MTM services under the Medicare Part D prescription drug benefit should hasten the development and offering of these services in community pharmacies.

Second-generation antidepressant discontinuation and depressive relapse in adult patients with bipolar depression: results of a retrospective database analysis.

BACKGROUND: To date, few postmarketing studies have addressed whether long-term prophylactic treatment with second-generation antidepressants (ADs) delays depressive episodes in patients with bipolar disorder. OBJECTIVE: The aim of this study was to compare the risk of depressive relapse between patients with bipolar disorder who took second-generation ADs>-6 months after depressive remission with those who discontinued AD use early. METHODS: Using a large US managed-care claims database, continuously enrolled bipolar subjects who took second-generation ADs after a depressive remission were identified between January 1, 1998, and December 31, 2002. Duration of AD and concurrent mood stabilizer use were based on coded diagnoses and pharmacy records. A Cox proportional hazards model was developed to predict time from depressive remission to next depressive relapse with continuous AD use, categorized as either >or=6 months or <6 months. Propensity scoring with greedy matching was used to help balance the observed background covariates and baseline disease severity between groups. RESULTS: Five hundred eighty-nine subjects met the inclusion criteria. A Kaplan-Meer estimate found that the median depressive relapse times for the continuous (ie, >or=6 months) and early discontinuation (ie, <6 months) AD treatment groups were 16.5 and 6.8 months, respectively (P<0.05). The Cox proportional hazards model with propensity score matching identified a significantly lower risk of depressive relapse over a 2-year period among those who continued AD treatment>or=6 months after remission, compared with those who discontinued treatment within 6 months (hazard ratio, 0.61 [95% CI, 0.42-0.88]; continuous vs early discontinuation, P<0.01). CONCLUSIONS: Continuous second-generation AD therapy for >or=6 months after depressive remission was associated with a lower risk of depressive relapse over a 2-year period in patients with bipolar depression. Given concerns regarding the risk of AD users with bipolar disorder switching to mania, an optimal prophylactic treatment after depressive remission should balance the risks between manic switching and depressive relapse.

Pharmaceutical care in community pharmacies: practice and research in the US.

OBJECTIVE: To describe the state of community pharmacy, including patient care services, in the US. FINDINGS: Chain pharmacies, including traditional chains, mass merchandisers, and supermarkets, comprise more than 50% of community pharmacies in the US. Dispensing of drugs remains the primary focus, yet the incidence of patients being counseled on medications appears to be increasing. More than 25% of independent community pharmacy owners report providing some patient clinical care services, such as medication counseling and chronic disease management. Most insurance programs pay pharmacists only for dispensing services, yet there are a growing number of public and private initiatives that reimburse pharmacists for cognitive services. Clinical care opportunities exist in the new Medicare prescription drug benefit plan, as it requires medication therapy management services for specific enrollees. DISCUSSION: The private market approach to healthcare delivery in the US, including pharmacy services, precludes national and statewide strategies to change the basic business model. To date, most pharmacies remain focused on dispensing prescriptions. With lower dispensing fees and higher operating costs, community pharmacies are focused on increasing productivity and efficiency through technology and technicians. Pharmacists remain challenged to establish the value of their nondispensing-related pharmaceutical care services in the private sector. As the cost of suboptimal drug therapy becomes more evident, medication therapy management may become a required pharmacy benefit in private drug insurance plans. Pharmacy school curricula, as well as national and state pharmacy associations, continually work to train and promote community pharmacists for these roles. Practice research is driven primarily by interested academics and, to a lesser degree, by pharmacy associations. CONCLUSIONS: Efficient dispensing of prescriptions is the primary focus of community pharmacies in the US. Some well designed practice-based research has been conducted, but there is no national research agenda or infrastructure. Reimbursement for cognitive services remains an infrequent, but growing, activity.

Accessing a new medication in Germany: a novel approach to assess a health insurance-related barrier.

PURPOSE: Knowledge of the existence, position, and magnitude of barriers to equitable healthcare is an important consideration in shaping healthcare policies. METHODS: The authors developed a novel three-dimensional person-time-related hurdle model and followed a cohort of 7358 statutorily (SHI) and 457 privately health insured (PHI) patients with migraine headaches at 377 primary-care practices (MediPlus, IMS Health) in the second to fourth year of the HealthCare Structural Reform Act in Germany. RESULTS: For SHI compared with PHI migraine patients, there was a hurdle to receiving sumatriptan at all (2.4-fold lower hazard, 95% confidence interval, 1.8-3.2). Among patients who received sumatriptan, frequency and intensity of use differed only minimally between SHI and PHI patients. CONCLUSIONS: These findings have implications for healthcare researchers and healthcare policies. The framework extends traditional hurdle models and can serve as a model for quantifying barriers to receipt of services under different funding policies.

Impact of community pharmacy automation on workflow, workload, and patient interaction.

OBJECTIVE: To compare workload productivity, workflow efficiency, and pharmacist-patient interaction in automated and nonautomated community pharmacies. DESIGN: Observational study. SETTING: Four community pharmacy sites within a regional pharmacy chain. STUDY PARTICIPANTS: 173 patients and 11 pharmacists. INTERVENTIONS: Patient surveys, pharmacist surveys, and direct observation. MAIN OUTCOME MEASURES: Patient satisfaction, frequency of pharmacist-patient interactions, and prescription dispensing productivity and efficiency. RESULTS: Results from the three nonautomated pharmacies were averaged and compared with results from the automated pharmacy. Patient satisfaction was generally favorable for both automated and nonautomated pharmacies, but scores for the automated site were significantly better on items measuring one domain, technical competence of pharmacy staff. No association was found between patient counseling and prescription workload in automated or nonautomated sites. Personnel at the automated site made significantly more offers to counsel patients, but the number of patients who received counseling did not differ significantly. Automation was associated with a higher number of prescriptions dispensed per full-time equivalent pharmacist and fewer technical dispensing tasks performed by pharmacists. CONCLUSION: Patient satisfaction was not related to the presence of an automated dispensing system. Automation was associated with higher prescription productivity, but actual counseling rates were no different from those observed in nonautomated pharmacies. The likelihood that a patient would receive counseling was not related to staffing levels, automation, or workload. Whether counseling occurred appeared to depend on factors other than automation.

Choice of atypical antipsychotic therapy for patients with schizophrenia: An analysis of a medicaid population.

BACKGROUND: In patients treated at Veterans Affairs facilities, demographicand clinical characteristics have been found to influence the choice of atypical antipsychotic drugs. However, little is known about the influences on the choice between olanzapine and risperidone in patients with schizophrenia enrolled in Medicaid. OBJECTIVE: The aim of this study was to determine whether demographicand/or clinical characteristics and/or medical-service utilization before treatment were related to the choice of olanzapine versus risperidone therapy using data from a Medicaid population with schizophrenia. METHODS: The study sample was identified in the North Carolina (NC)Medicaid claims database. Data were included from patients aged 18 to 64 years who were diagnosed with schizophrenia; had initiated treatment with olanzapine or risperidone between July 1, 1998, and October 31, 2000; had not used atypical antipsychotics during the 6 months before the start of treatment; and were continuously eligible in the NC Medicaid program during the 6 months before the start of treatment. Multivariate logistic regression models were used to estimate the likelihood of the choice of olanzapine or risperidone associated with patients' demographic and clinical characteristics and medical-service utilization during the 6 months before the initiation of treatment. RESULTS: A total of 764 patients (383 women, 381 men; mean age, 42.1 years)were included in the analysis: 420 were initially prescribed olanzapine and 344 were prescribed risperidone. Men were more likely than women to be prescribed olanzapine compared with risperidone. Patients who had a hospitalization related to a psychiatric condition during the pretreatment period were more likely to be prescribed olanzapine compared with risperidone (OR = 1.530; P = 0.043). Significant regional variation in the likelihood of prescribing olanzapine or risperidone was found, with patients being prescribed risperidone at a higher rate compared with olanzapine in 2 counties with the largest schizophrenic populations. CONCLUSIONS: In this study of data from patients with schizophrenia identified in the NC Medicaid claims database, sex, a history of psychiatric-related hospitalization, and geographic residence were found to be correlated with the selection of treatment with olanzapine versus risperidone. These findings need to be confirmed in large, randomized, prospective studies.

Inappropriate medication use and health outcomes in the elderly.

Inappropriate medication use is a major problem for the elderly. Although increasing attention has been paid to inappropriate prescription medication use, most previous research has been limited to the investigation of prevalence and trends. Few studies provide the empirical evidence for the adverse effect of inappropriate medication use on health outcomes at the national level. This study is the first attempt to assess the relationship between inappropriate prescription use and health status for the elderly in the United States. Based on the 1996 Medical Expenditure Panel Survey, inappropriate medication use in a national representative elderly population was first identified using Beers criteria. A survey type of ordered probit model was then estimated to quantify the effect of inappropriate drug use on patient self-perceived health status measured using a five-point scale (poor, fair, good, very good, and excellent). After controlling for a set of possible confounding factors, it was found that individuals using inappropriate medications in Round 1 were more likely than those not using inappropriate medications to report poorer health status in Round 2. Other risk factors for poor health status include a higher number of prescriptions, being black, having low education, and having one or more chronic diseases. This study provides strong evidence of a significant adverse effect of inappropriate medication use on patient health status. These findings lend partial support to the use of Beers criteria in assessing the quality of prescribing and the appropriateness of medication use in the elderly population.

Current status of prospective drug utilization review.

BACKGROUND: The Omnibus Budget Reconciliation Act of 1990 offered the promise that prospective drug utilization review (pDUR) systems would improve the quality of drug prescribing and patient drug use. There is little evidence that this promise has been fulfilled. To the contrary, there is growing evidence that suboptimal use of drugs (in terms of preventable drug-related morbidity) is at least as costly as the prescription drugs themselves. Online computerized pDUR has been the subject of numerous critical examinations in the pharmacy and medical literature. Recent publications have sought to illustrate perceived shortcomings in the DUR systems currently in use. OBJECTIVE: We focus on the state of the art with regard to pDUR, what is known about its effectiveness, and how emerging technologies may change pDUR and consider the work that may be needed to establish its effectiveness. SUMMARY: A growing body of literature documents numerous problems and concerns with respect to the quality of DUR criteria, DUR alerts, and the response of health care professionals to these alerts. Problems with the current pDUR "system" can be grouped into those involving technical aspects (e.g., duplicate messaging from in-store and online systems, or message text limitations) and into those involving human aspects, specifically how pharmacists and other health care providers interpret and respond to potential drug therapy problem alerts generated by the electronic systems. CONCLUSION: DUR is a quality assurance system that holds promise as a tool that, if implemented effectively, could enhance appropriate drug use. We believe a more systematic approach to DUR is needed. Evaluation and management of public and private pDUR systems must link documentation of processes of care, such as pharmacists. cognitive services, patient interventions, etc. To address technical aspects, we strongly recommend (a) a national effort to validate DUR screen criteria relying upon evidence-based studies and (b) adoption of a minimal set of.critical. pDUR screen criteria by pharmacy service providers and third-party intermediaries, including pharmacy benefit managers. To address the human component of pDUR systems, we advocate (a) adoption of performance standards for pharmacists and (b) explicit remuneration for time spent identifying and responding to drug therapy problems.

Quantifying delay in access to new medical treatment: an application of risk advancement period methodology.

BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.

The disparity in access to new medication by type of health insurance: lessons from Germany.

BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.